Exercise Tolerance in Patients With Decompensated Heart Failure

April 20, 2015 updated by: Wellington Yamaguti, Hospital Sirio-Libanes

Effects of Bilevel Positive Airway Pressure on Exercise Tolerance in Patients With Decompensated Heart Failure

The purpose of this study is to evaluate the effects of airway bilevel positive pressure on the improvement of exercise tolerance in patients with decompensated heart failure.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Heart failure causes limitation of functional capacity and worsening of exercise tolerance. The airway pressure as adjuvant of cardiac rehabilitation has demonstrated improvement of functional capacity, decrease of respiratory work, increase of oxygenation and pulmonary compliance. Objective: to evaluate the effectiveness of the bilevel positive airway pressure (BILEVEL) in the increase of exercise tolerance in patients with decompensated heart failure. Method: this is a cross-over randomized clinical trial, with individuals who will undergo a submaximal progressive exercise test of the lower limbs with a cycle-ergometer using continuous positive airway pressure (CPAP) and BILEVEL in a random order. Patients will also be evaluated using a health related quality of life questionnaire, pulmonary function test, inspiratory muscle and peripheral muscle strength tests. Hypothesis: The increase in exercise tolerance might be greater during the use of BILEVEL.

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • São Paulo, Brazil, 01308-050
        • Hospitalsiriolibanes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • subjects who has heart failure functional class II or III of New York heart association
  • over 18 years
  • non-smokers
  • without cognitive or motor deficit
  • without vasoactive drugs or low doses
  • without recent acute myocardial myocardium (<1 year)
  • without recent cardiac surgery (<1 year)
  • without pulmonary disease
  • without bronchodilators

Exclusion Criteria:

  • unstable angina
  • atrial fibrillation and atrioventricular block third degree
  • frequent vomiting
  • respiratory instability while collecting data

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Bilevel
The intervention will be performed using BiLevel ventilation mode with EPAP=10 cmH2O and a IPAP which manages 6-8ml/kg tidal volume.
Device: BiLevel
The intervention will be performed using BiLevel ventilation mode with EPAP=10 cmH2O and a IPAP which manages 6-8ml/kg tidal volume.
Other Names:
  • BiPAP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Endurance time of exercise in cycle ergometer.
Time Frame: 4 days
4 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dyspnea
Time Frame: 4 days
Dyspnea will be evaluated by means of the modified Borg scale before and after exercise.
4 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Sirio-Libanes

Investigators

  • Principal Investigator: Wellington Yamaguti, Hospital Sírio-Libanês

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Actual)

April 1, 2015

Study Completion (Actual)

April 1, 2015

Study Registration Dates

First Submitted

April 20, 2014

First Submitted That Met QC Criteria

April 23, 2014

First Posted (Estimate)

April 25, 2014

Study Record Updates

Last Update Posted (Estimate)

April 22, 2015

Last Update Submitted That Met QC Criteria

April 20, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • hsl 2013-48

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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